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Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce the incidence, duration, and severity of post cardiotomy delirium?
Pilot study for feasibility and safety, n = 40, haloperidol 1mg vs. placebo BID administered night before and day of surgery, then continued for total 72hrs post-op, if delirium occurs study drug is stopped and usual standard of care implemented by MRP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haloperidol | Active Comparator | Haloperidol 1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery |
|
| Placebo | Placebo Comparator | 1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haloperidol | Drug | 1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery | If a participant does not develop delirium post operatively, then the confusion assessment method (CAM)will be monitored for 24 hours after the study medication ends. Patients will be followed up until seven days or until discharge if no delirium occurs, or if delirium is detected, up to 30 days or until discharge | Participants will be followed for the duration of their hospital stay to a maximum of 30 days. |
| Safety monitoring of low dose Haloperidol use in patients post cardiac surgery | If a participant does not develop delirium post operatively, then the confusion assessment method (CAM)will be monitored for 24 hours after the study medication ends. Patients will be followed up until seven days or until discharge if no delirium occurs, or if delirium is detected, up to 30 days or until discharge | Participants will be followed for the duration of their hospital stay to a maximum of 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of delirium | Participants will be followed for the duration of their hospital stay to a maximum of 30 days | |
| Delirium severity | Participants will be followed for the duration of their hospital stay to a maximum of 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| An economic analysis will be completed to determine if Haloperidol prophylaxis resulted in any cost savings | Participants will be followed for the duration of their hospital stay to a maximum of 30 days |
Inclusion Criteria:
Greater than or equal to 70 years of age, undergoing a median sternotomy OR 60-69yrs of age with one or more of the risk factors:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre Lamy, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Site | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Term |
|---|---|
| D006220 | Haloperidol |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Placebo | Drug | 1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery |
|
| Total length of stay (LOS), with breakdown for intensive care unit (ICU) days and ward days | Participants will be followed for the duration of their hospital stay to a maximum of 30 days |
| Duration of delirium | Participants will be followed for the duration of their hospital stay to a maximum of 30 days |